Lisdexamfetamine dimesylate and mixed amphetamine salts extended-release in children with ADHD: a double-blind, placebo-controlled, crossover analog classroom study.

Abstract

BACKGROUND:

Lisdexamfetamine dimesylate is a therapeutically inactive prodrug in which d-amphetamine is covalently bound to l-lysine, a naturally occurring amino acid. Pharmacologically active d-amphetamine is released from lisdexamfetamine following oral ingestion.

METHODS:

This phase 2, randomized, double-blind, placebo- and active-controlled crossover study compared the efficacy and safety of lisdexamfetamine (LDX: 30, 50, or 70 mg) with placebo, with mixed amphetamine salts extended-release (MAS XR: 10, 20, or 30 mg) included as a reference arm of the study, in 52 children aged 6 to 12 years with attention-deficit/hyperactivity disorder (ADHD) in an analog classroom setting. The primary efficacy measure was the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) Rating Scale; secondary efficacy measures included the Permanent Product Measure of Performance (PERMP) Derived Measures, and the Clinical Global Impression (CGI) Scale.

RESULTS:

LDX treatment significantly improved scores on SKAMP-deportment, SKAMP-attention, PERMP-attempted, PERMP-correct, and CGI-improvement from baseline. Adverse events were similar for both active treatments.

CONCLUSIONS:

In a laboratory classroom environment, LDX significantly improved ADHD symptoms versus placebo in school-age children with ADHD.

• Authors: Joseph Biederman, Samuel W Boellner, Ann Childress, Frank A Lopez, Suma Krishnan, Yuxin Zhang
• Journal: Biological psychiatry (Biol Psychiatry) Vol. 62 Issue 9 Pg. 970-6 (Nov 01 2007) ISSN: 0006-3223 [Print] United States
• PMID: 17631866 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Central Nervous System Stimulants
• Delayed-Action Preparations
• Amphetamine
• Lisdexamfetamine Dimesylate
• Dextroamphetamine

Topics

• Amphetamine (therapeutic use)
• Attention Deficit Disorder with Hyperactivity (drug therapy)
• Central Nervous System Stimulants (therapeutic use)
• Child
• Cross-Over Studies
• Delayed-Action Preparations (therapeutic use)
• Dextroamphetamine (therapeutic use)
• Double-Blind Method
• Female
• Humans
• Lisdexamfetamine Dimesylate
• Male
• Psychiatric Status Rating Scales
• Time Factors
• Treatment Outcome